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Search / Trial NCT05038462

Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

Launched by INSTITUT D'INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER · Sep 3, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Fetal Growth Retardation Fetal Growth Restriction Intrauterine Growth Restriction Neurodevelopment Lactoferrin Dha

ClinConnect Summary

This clinical trial, called "Fetal Brain Care," is studying ways to support brain development in babies that are not growing as expected during pregnancy, a condition known as fetal growth restriction. The researchers want to see if taking specific supplements—Lactoferrin and DHA (a type of omega-3 fatty acid)—can help improve outcomes for these babies. Pregnant women who are between 24 and 32 weeks along and have been diagnosed with this condition might be eligible to participate. They need to have a single, healthy baby on the ultrasound, without any major birth defects.

Participants in the study will be randomly assigned to receive either the supplements or a placebo (a harmless substance with no active ingredients). This means they won't know which group they are in, but they can expect to be monitored closely throughout the trial. The study is currently looking for women to join, so if you think you might qualify, it could be an opportunity to potentially help your baby's development while contributing to important research.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Singleton pregnancies
  • Non-malformed fetus
  • Pregnancies with fetal growth restriction
  • 24-32.6 weeks of gestation
  • Exclusion Criteria:
  • Chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period
  • Critical Doppler study suggesting the need for delivery within the next 14 days at the time of diagnosis: reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility \>95th centile
  • Maternal mental or psychiatric disorders
  • Maternal allergy to cow's milk protein

About Institut D'investigacions Biomèdiques August Pi I Sunyer

The Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) is a leading biomedical research institute based in Barcelona, Spain, dedicated to advancing scientific knowledge and innovation in health and disease. Affiliated with the University of Barcelona, IDIBAPS fosters a multidisciplinary approach to research, integrating clinical and basic science to enhance understanding of various medical conditions. The institute emphasizes collaboration among researchers, clinicians, and industry partners to translate research findings into effective therapies and improve patient care. With a commitment to excellence, IDIBAPS plays a pivotal role in shaping the future of biomedical science and healthcare.

Locations

Barcelona, , Spain

Barcelona, , Spain

Badalona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Esplugues De Llobregat, , Spain

Barcelona, , Spain

Hospitalet De Llobregat, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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